Commission Regulation (EC) No 889/2008Show full title

CHAPTER 1 Minimum control requirements

Article 63 Control arrangements and undertaking by the operator

1. When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:

(a) a full description of the unit and/or premises and/or activity;

(b) all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules;

(c) the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator's production chain.

Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator.

2. The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:

(a) to perform the operations in accordance with the organic production rules;

(b) to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;

(c) to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production.

The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures.

3. For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:

(a) Name and address of operator;

(b) Location of premises and, where appropriate, parcels (land register data) where operations are carried out;

(c) Nature of operations and products;

(d) Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;

(e) In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned;

(f) The name of the approved body to which the operator entrusted control of his undertaking, where the Member State has implemented the control system by approving such bodies.

Article 64 Modification of control arrangements

The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.

Article 65 Control visits

1. The control authority or control body shall carry out at least once a year a physical inspection of all operators.

2. The control authority or control body may take samples for testing of products not authorised for organic production or for checking production techniques not in conformity with the organic production rules. Samples may also be taken and analysed for detecting possible contamination by products not authorised for organic production. However, such analysis shall be carried out where the use of products not authorised for organic production is suspected.

3. A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative.

4. Moreover, the control authority or control body shall carry out random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with the organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products.

Article 66 Documentary accounts

1. Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify:

(a) the supplier and, where different, the seller, or the exporter of the products;

(b) the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs;

(c) the nature and the quantities of organic products held in storage at the premises;

(d) the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities;

(e) in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.

2. The documentary accounts shall also comprise the results of the verification at reception of organic products and any other information required by the control authority or control body for the purpose of proper control. The data in the accounts shall be documented with appropriate justification documents. The accounts shall demonstrate the balance between the input and the output.

3. Where an operator runs several production units in the same area, the units for non organic products, together with storage premises for input products must also be subject to the minimum control requirements.

Article 67 Access to facilities

1. The operator shall:

(a) give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents;

(b) provide the control authority or control body with any information reasonably necessary for the purposes of the control;

(c) submit, when requested by the control authority or control body, the results of its own quality assurance programmes.

2. In addition to the requirements set out in paragraph 1, importers and first consignees shall submit the information on imported consignments referred to in Article 84.

Article 68 Documentary evidence

For the purpose of the application of Article 29(1) of Regulation (EC) No 834/2007 the control authorities and the control bodies shall use the model of the documentary evidence set out in Annex XII to this Regulation.

Article 69 Vendor declaration

For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.